Comparison of Corneal Grafts Cultured in Serum-Free Versus Corneal Grafts Cultured in Serum Supplemented Culture Media - Full Text View

Sponsors and Collaborators:	Klinikum Chemnitz gGmbH German Research Foundation Koordinierungszentrum für klinische Studien Dresden
Information provided by:	Klinikum Chemnitz gGmbH
ClinicalTrials.gov Identifier:	NCT00623584

Purpose

The goal of this clinical trial is to compare the quality of corneal grafts cultured in a serum-free culture medium with a defined composition versus corneal grafts cultured in a standard serum supplemented culture medium transplanted in patients with decompensated corneal dystrophy

Condition	Intervention
Fuch's Endothelial Dystrophy Pseudophakic Bullous Keratopathy	Procedure: Corneal transplantation

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	In Vitro and Clinical Comparison of Corneal Grafts Cultured in Serum Free Medium or Standard Serum Supplemented Medium in Patients With Degeneration of the Corneal Endothelium

Further study details as provided by Klinikum Chemnitz gGmbH:

Primary Outcome Measures:

The primary outcome is the endothelial cell density of the corneal grafts prior to and after the transplantation procedure [ Time Frame: The measurment will be performed prior to and 1, 4, 12, 24, 36, 48 and 60 months after the transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary study outcomes are immune mediated graft rejection, non-immune mediated graft failure, as well as the incidence of corneal edema, corneal opacities and corneal neovascularisation. [ Time Frame: 1,4,12, 24, 36, 48 and 60 month after the transplantation ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	April 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients in this arm randomly receive a corneal graft cultured in a serum free culture medium	Procedure: Corneal transplantation Full thickness penetrating keratoplasty
2: Active Comparator Patients in this arm randomly receive a corneal graft cultured in a serum supplemented culture medium	Procedure: Corneal transplantation Full thickness penetrating keratoplasty

Detailed Description:

The primary objective of this clinical trial is to test the equivalence of the quality of the corneal grafts cultured under serum free conditions to corneal grafts cultured in the Minimal Essential Medium supplemented with 2% fetal calf serum, based on a parallel comparison of the endothelial cell density of paired corneal grafts deriving from single donors at different time points before and after the grafting procedure. In addition, the safety of the clinical use of corneal grafts cultured in both media will be determined. The graft survival rate during the follow-up period will be quantified in regard to immune mediated graft rejection and non-immune mediated graft failure, as well as the incidence of corneal edema, corneal opacities and corneal neovascularisation.

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients between 50 and 85 years of age
Clinically proven Fuchs corneal dystrophy or secondary decompensation the corneal endothelium (e. g. after surgical intervention in the anterior segment of the eye)
Patient informed consent

Exclusion Criteria:

Previous penetrating keratoplasty
Corneal neovascularisation
Pathologic changes in the anterior segment of the eye (anterior / posterior synechiae, uveitis)
Glaucoma
Aphakia
Infectious diseases of the cornea
Neurodermitis
Participation of the patient in another clinical trial within the last four weeks that precede the recruitment
The patient is unlikely to comply with the requirements of the protocol
Previous or current abuse of medications, narcotics or alcohol
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623584

Contacts

Contact: Katrin Engelmann, MD	+ 49 371 333 33230	k.engelmann@skc.de
Contact: Simo Murovski, MD	+ 49 371 333 31022	s.murovski@skc.de

Locations

Germany, Sachsen-Anhalt
Universitäts Augenklinik
Halle (Saale), Sachsen-Anhalt, Germany, 06120
Germany, Saxony
Augenklinik, Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany, 091116

Sponsors and Collaborators

Klinikum Chemnitz gGmbH

German Research Foundation

Koordinierungszentrum für klinische Studien Dresden

More Information

Publications:

Hempel B, Bednarz J, Engelmann K. Use of a serum-free medium for long-term storage of human corneas. Influence on endothelial cell density and corneal metabolism. Graefes Arch Clin Exp Ophthalmol. 2001 Oct;239(10):801-5.

Bednarz J, Doubilei V, Wollnik PC, Engelmann K. Effect of three different media on serum free culture of donor corneas and isolated human corneal endothelial cells. Br J Ophthalmol. 2001 Dec;85(12):1416-20.

Uphoff J, Bednarz J, Engelmann K. [Follow-up of endothelial cell density after perforating keratoplasty. Effect of donor and recipient-related factors] Ophthalmologe. 2001 Jun;98(6):550-4. German.

Møller-Pedersen T, Hartmann U, Møller HJ, Ehlers N, Engelmann K. Evaluation of potential organ culture media for eye banking using human donor corneas. Br J Ophthalmol. 2001 Sep;85(9):1075-9.

Møller-Pedersen T, Hartmann U, Ehlers N, Engelmann K. Evaluation of potential organ culture media for eye banking using a human corneal endothelial cell growth assay. Graefes Arch Clin Exp Ophthalmol. 2001 Oct;239(10):778-82.

Responsible Party:	Eye Clinic Chemnitz ( Prof. Dr. med. Katrin Engelmann )
Study ID Numbers:	SKC001SFM08
Study First Received:	February 13, 2008
Last Updated:	February 25, 2008
ClinicalTrials.gov Identifier:	NCT00623584
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Klinikum Chemnitz gGmbH:

penetrating keratoplasty
corneal transplantation
corneal grafting
corneal grafts

culture media
corneal culturing
in vitro culturing

Study placed in the following topic categories:

Corneal Diseases
Corneal dystrophy
Genetic Diseases, Inborn
Corneal Dystrophies, Hereditary
Eye Diseases

Corneal dystrophy, Fuchs' endothelial, 1
Fuchs' Endothelial Dystrophy
Corneal Edema
Eye Diseases, Hereditary
Edema

ClinicalTrials.gov processed this record on January 16, 2009